Method and system for delivering a medical electrical lead within a venous system

• US 6,733,500 B2
• Filed: 04/24/2002
• Issued: 05/11/2004
• Est. Priority Date: 03/31/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Meregotte, Pedro A., Kelley, James F., Spear, Stanten C., Maier, John J., Vaughn, James H., Sommer, John L., Gardeski, Kenneth C., Hine, Douglas S., Bjorklund, Vicki L.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US10/131,672
• Publication Number:
  US 20020165537A1
• Time in Patent Office: 748 Days
• Field of Search: 606/1, 606/41, 607/115, 607/116, 607/119, 607/122, 607/126, 604/164.01, 604/164.02, 604/164.13, 604/264
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/0578 : having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 : Coronary sinus electrodes

Abstract

A loading device for loading a guide wire within a medical electrical lead that includes a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end. An engagement cavity receives and properly orientates the lead distal tip to align the lumen of the lead with the opening of the navigation portion during the loading of the guide wire within the lead. A first side wall is spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, and the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device.

Claims

1. A loading device for loading a guide wire within a medical electrical

lead having a lead distal tip and a lumen for receiving the guide wire, the loading device comprising:

a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end;

an engagement cavity receiving and properly orienting the lead distal tip to align the lumen of the lead with the opening of the navigation portion during the loading of the guide wire within the lead; and

a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device.

2. The loading device of claim 1, further comprising an insertion guide positioned on the loading device to properly position the lead distal tip within the engagement cavity.

3. The loading device of claim 1, wherein the engagement cavity is shaped to form a minimum clearance fit about the lead distal tip.

4. The loading device of claim 3, wherein the lead includes a lead body distal portion extending from the lead distal tip, wherein the lead body distal portion is fixedly engaged within the loading device.

5. The loading device of claim 1, further comprising:

a first opening formed at the front end of navigation portion; and

a second opening formed at the back end of navigation portion and coupling

the navigation portion with the engagement cavity, wherein the engagement cavity aligns the lumen of the lead with the second opening.

6. The loading device of claim 1, wherein the engagement cavity is sized to extend approximately 0.002 inches from the lead distal tip when the lead distal tip is inserted within the engagement cavity.

7. The loading tool of claim 1, wherein the lead is a side-lumen lead.

8. The loading tool of claim 7, further comprising a ramp portion directing the guide wire out of the engagement cavity as guide wire is extended through the side lumen lead.

9. The loading tool of claim 1, wherein the lead is an over-the-wire lead.

10. A method of delivering a medical electrical lead within a coronary venous system, comprising the steps of:

establishing venous access to the coronary venous system using an introducer tool kit;

choosing a delivery sheath from a plurality of delivery sheaths corresponding to a desired approach to a coronary sinus of the coronary venous system;

positioning the delivery sheath within the venous access;

inserting the lead within a loading device;

inserting a guide wire within a navigation portion of the loading device, the navigation portion directing the guide wire within a lumen of the lead;

advancing the guide wire through a slot formed by a first side wall spaced from a second side wall and extending along an outer portion of the navigation portion to remove the lead having the guide wire inserted therein from the loading device;

inserting the distal tip of the medical electrical lead within the delivery sheath; and

guiding advancement of the distal tip of the medical electrical lead to a target site within the coronary venous system using the guide wire.

11. The method of claim 10, further comprising the steps of:

coupling a hemostasis valve over a proximal portion of the delivery sheath; and

decoupling the hemostasis valve from the delivery sheath and

advancing the hemostasis valve over a connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

12. The method of claim 11, further comprising the step of inserting a stylet, having a stylet knob, within the lead to assist in guiding the advancement of the lead to the target site, and wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over the stylet knob to remove the hemostasis valve from the medical electrical lead.

13. The method of claim 11, wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over an anchoring sleeve positioned on the lead.

14. The method of claim 11, wherein the step of positioning the delivery sheath includes inserting the delivery sheath within the coronary venous system using one of a steerable catheter and an introducer guide wire.

15. The method of claim 14, further comprising the step of securing excess length of one of the guide wire and the introducer guide wire to prevent the excess length from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire.

16. The method of claim 11, wherein the connector is an IS-1 connector.

17. The method of claim 11, wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

18. The method of claim 11, wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.

19. A system for delivering a medical electrical lead within a coronary venous system, the medical electrical lead extending from a connector to a distal tip and having a lead lumen located at the distal tip, the system comprising:

an introducer kit establishing venous access to the coronary venous system;

a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system, establishing a navigation pathway within the coronary venous system through the venous access;

a hemostasis valve coupled to a delivery sheath of the plurality of delivery sheaths; and

a loading device loading a guide wire insertable within the lead lumen, the loading device including a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end, an engagement cavity receiving and properly orienting the lead distal tip during the loading of the guide wire within the lead, and a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device, and wherein the guide wire guides delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system through the hemostasis valve and the delivery sheath, wherein, subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

20. The system of claim 19, further comprising an insertion guide positioned on the loading device to properly position the lead distal tip within the engagement cavity.

21. The system of claim 19, wherein the engagement cavity is shaped to form a minimum clearance fit about the lead distal tip.

22. The system of claim 21, wherein the lead includes a lead body distal portion extending from the lead distal tip, wherein the lead body distal portion is fixedly engaged within the loading device.

23. The system of claim 19, further comprising:

a first opening formed at the front end of navigation portion; and

a second opening formed at the back end of navigation portion and coupling

the navigation portion with the engagement cavity, wherein the engagement cavity aligns the lumen of the lead with the second opening.

24. The system of claim 22, wherein the engagement cavity is sized to extend approximately 0.002 inches from the lead distal tip when the lead distal tip is inserted within the engagement cavity.

25. The system of claim 19, further comprising a ramp portion positioned within the engagement cavity, wherein the lead is a side-lumen lead and the ramp portion directs the guide wire out of the engagement cavity as guide wire is extended through the side lumen lead.

26. The system of claim 19, further comprising a stylet, having a stylet knob, inserted within the lead to assist in guiding the advancement of the lead to the target site, wherein the hemostasis valve is advanced over the stylet knob to remove the hemostasis valve from the medical electrical lead.

27. The system of claim 26, further comprising an anchoring sleeve position along the lead, wherein the hemostasis valve is advanced over the anchoring sleeve to remove the hemostasis valve from the medical electrical lead.

28. The system of claim 19, wherein the tool kit includes a steerable catheter and an introducer guide wire, and wherein the delivery sheath is inserted within the coronary venous system through the venous access using one of the steerable catheter and the introducer guide wire.

29. The system of claim 28, further comprising a guide wire clip capable of being positioned in one of a non-engaging open position and an engaging closed position, the guide wire clip securing excess length of one of the guide wire and the introducer guide wire to prevent the guide wire and the introducer guide wire from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire when the guide wire clip is in the closed position.

30. The system of claim 19, wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

31. The system of claim 19, wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.

32. The system of claim 19, wherein the connector is an IS-1 connector.